{"id":"abametapir","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"C-C chemokine receptor type 5","category":"target"},{"label":"CCR5","category":"gene"},{"label":"CCR8","category":"gene"},{"label":"CCR1","category":"gene"},{"label":"P03AX07","category":"atc"},{"label":"Topical","category":"route"},{"label":"Lotion","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Pediculosis capitis","category":"indication"},{"label":"Hatchtech","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Erythema","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"3.2%","severity":"common","organSystem":""},{"effect":"Scalp Erythema/Edema","drugRate":"3.2%","severity":"common","organSystem":""},{"effect":"Skin burning sensation","drugRate":"2.6%","severity":"common","organSystem":""},{"effect":"Contact dermatitis","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Eye irritation","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Eye Irritation","drugRate":"1.2%","severity":"common","organSystem":""},{"effect":"Scalp Pruritus","drugRate":"1.4%","severity":"common","organSystem":""},{"effect":"Hair color changes","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Pruritus","drugRate":"1%","severity":"common","organSystem":""}],"specialPopulations":{"Pregnancy":"There are no available data on XEGLYZE use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In embryofetal development studies conducted with oral administration of abametapir during organogenesis, no evidence of fetal harm or malformations, independent of maternal toxicity were observed in pregnant rats and rabbits at doses that produced exposures up to 50 times and equivalent to the maximum recommended human dose (MRHD) in rats and rabbits, respectively. The highest dose evaluated in rabbits was limited due to maternal toxicity associated with the vehicle used in the study (see Data).The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.DataAnimal Data Systemic embryofetal development studies were performed in rats and rabbits. Oral doses of 10, 25 and 75 mg/kg/day abametapir were administered during the period of organogenesis (gestational days - 17) to pregnant rats. In the presence of maternal toxicity, embryofetal toxicity (lower fetal body weights and delayed ossification) was noted at 75 mg/kg/day. No treatment related effects on malformations were noted at 75 mg/kg/day (50 times the MRHD based on Cmax comparisons","Geriatric use":"Clinical studies of XEGLYZE did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger subjects.","Paediatric use":"The safety and effectiveness of XEGLYZE have been established in pediatric patients months of age and older [see Clinical Pharmacology (12) and Clinical Studies (14)]. The safety and effectiveness of XEGLYZE have not been established in pediatric patients below the age of months. XEGLYZE is not recommended in pediatric patients under months of age because of the potential for increased systemic absorption due to high ratio of skin surface to body mass and the potential for an "},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Hatchtech","patents":[{"applNo":"N206966","source":"FDA Orange Book","status":"Active","expires":"Oct 28, 2026","useCode":"U-2863","territory":"US","drugProduct":true,"patentNumber":"7812163","drugSubstance":false},{"applNo":"N206966","source":"FDA Orange Book","status":"Active","expires":"Dec 17, 2034","useCode":"U-2863","territory":"US","drugProduct":true,"patentNumber":"10292389","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ABAMETAPIR","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:10:03.509947+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:10:03.509859+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Abametapir","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:10:10.536780+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:10:09.047290+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ABAMETAPIR","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:10:09.431124+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Zinc sequestering agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:10:10.536737+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2205807/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:10:10.161553+00:00"}},"allNames":"xeglyze","offLabel":[],"synonyms":["abametapir","xeglyze","Ha44"],"timeline":[{"date":"2020-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from DR REDDYS LABS SA to Hatchtech"},{"date":"2020-07-24","type":"positive","source":"DrugCentral","milestone":"FDA approval (Dr Reddys Labs Sa)"}],"brandName":"Xeglyze","ecosystem":[{"indication":"Pediculosis capitis","otherDrugs":[{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"},{"name":"lindane","slug":"lindane","company":"Reed And Carnrick"},{"name":"malathion","slug":"malathion","company":"Taro Pharms North"},{"name":"permethrin","slug":"permethrin","company":""}],"globalPrevalence":null}],"mechanism":{"target":"C-C chemokine receptor type 5","novelty":"Follow-on","targets":[{"gene":"CCR5","source":"DrugCentral","target":"C-C chemokine receptor type 5","protein":"C-C chemokine receptor type 5"},{"gene":"CCR8","source":"DrugCentral","target":"C-C chemokine receptor type 8","protein":"C-C chemokine receptor type 8"},{"gene":"CCR1","source":"DrugCentral","target":"C-C chemokine receptor type 1","protein":"C-C chemokine receptor type 1"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Xeglyze (ABAMETAPIR) is a small molecule that acts as a selective antagonist of the C-C chemokine receptor type 5 (CCR5), a key receptor involved in the signaling pathway that promotes the growth and survival of head lice."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Abametapir","title":"Abametapir","extract":"Abametapir, sold under the brand name Xeglyze, is a medication used for the treatment of head lice infestation in people six months of age and older.","wiki_history":"== History ==\nThe U.S. Food and Drug Administration (FDA) approved abametapir based on evidence from two identical clinical trials of 699 participants with head lice. The trials were conducted at fourteen sites in the United States.\n\nThe benefit and side effects of abametapir were evaluated in two clinical trials that enrolled participants with head lice who were at least six months old.\n\nAbout half of all enrolled participants was randomly assigned to abametapir and the other half to placebo. Abametapir lotion or placebo lotion were applied once as a ten-minute treatment to infested hair. The benefit of abametapir in comparison to placebo was assessed after 1, 7 and 14 days by comparing the counts of participants in each group who were free of live lice."},"commercial":{"launchDate":"2020","_launchSource":"DrugCentral (FDA 2020-07-24, DR REDDYS LABS SA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5403","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ABAMETAPIR","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ABAMETAPIR","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Abametapir","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:20:27.045808","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:10:11.819849+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"benzyl benzoate","drugSlug":"benzyl-benzoate","fdaApproval":"1976-09-02","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"malathion","drugSlug":"malathion","fdaApproval":"1982-08-02","patentExpiry":"Feb 1, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"dimethicone","drugSlug":"dimethicone","fdaApproval":"1997-06-26","relationship":"same-class"},{"drugName":"benzyl alcohol","drugSlug":"benzyl-alcohol","fdaApproval":"2009-04-09","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"abametapir","indications":{"approved":[{"name":"Pediculosis capitis","source":"DrugCentral","snomedId":81000006,"regulator":"FDA","eligibility":"patients 6 months of age and older"}],"offLabel":[],"pipeline":[]},"currentOwner":"Hatchtech","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"benzyl-benzoate","brandName":"benzyl benzoate","genericName":"benzyl benzoate","approvalYear":"1976","relationship":"same-class"},{"drugId":"malathion","brandName":"malathion","genericName":"malathion","approvalYear":"1982","relationship":"same-class"},{"drugId":"dimethicone","brandName":"dimethicone","genericName":"dimethicone","approvalYear":"1997","relationship":"same-class"},{"drugId":"benzyl-alcohol","brandName":"benzyl alcohol","genericName":"benzyl alcohol","approvalYear":"2009","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02061813","phase":"PHASE1","title":"Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2014-01","conditions":["Head Lice"],"enrollment":40,"completionDate":"2014-05"},{"nctId":"NCT01518699","phase":"PHASE1","title":"Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2012-01","conditions":["Pediculosis"],"enrollment":57,"completionDate":"2012-05"},{"nctId":"NCT02097485","phase":"PHASE2","title":"Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2014-05","conditions":["Head Lice Infestation"],"enrollment":50,"completionDate":"2014-10"},{"nctId":"NCT02060903","phase":"PHASE3","title":"A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2014-02","conditions":["Head Lice Infestation"],"enrollment":379,"completionDate":"2014-08"},{"nctId":"NCT02062060","phase":"PHASE3","title":"Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2014-02","conditions":["Head Lice Infestation"],"enrollment":325,"completionDate":"2014-08"},{"nctId":"NCT02010333","phase":"PHASE2","title":"A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2013-04","conditions":["Head Lice Infestation"],"enrollment":22,"completionDate":"2014-08"},{"nctId":"NCT02062073","phase":"PHASE1","title":"Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2014-01","conditions":["Head Lice"],"enrollment":238,"completionDate":"2014-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Lotion","formulations":[{"form":"LOTION","route":"TOPICAL","productName":"Xeglyze"}]},"_patentsChecked":true,"crossReferences":{"MMSL":"38681","NDDF":"018457","UNII":"6UO390AMFB","INN_ID":"9829","RXNORM":"2475532","UMLSCUI":"C4519258","chemblId":"CHEMBL2205807","ChEMBL_ID":"CHEMBL2205807","KEGG_DRUG":"D10687","DRUGBANK_ID":"DB11932","PDB_CHEM_ID":"EI3","PUBCHEM_CID":"15664","SNOMEDCT_US":"926368006"},"formularyStatus":[],"originalProduct":{"form":"LOTION","route":"TOPICAL","company":"Dr. Reddys Laboratories Inc.","brandName":"Xeglyze","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2020-","companyName":"Dr Reddys Labs Sa","relationship":"Original Developer"},{"period":"present","companyName":"Hatchtech","relationship":"Current Owner"}],"publicationCount":13,"therapeuticAreas":["Other"],"atcClassification":{"source":"DrugCentral","atcCode":"P03AX07","allCodes":["P03AX07"]},"biosimilarFilings":[],"originalDeveloper":"Dr Reddys Labs Sa","recentPublications":[],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Hatchtech","companyId":"hatchtech","modality":"Small molecule","firstApprovalDate":"2020","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:10:11.819849+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}